MAUDE Adverse Event Report: Terumo BCT RIKA; RIKA PLASMA SEPARATION SET

Catalog Number	6212001
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process, a follow-up report will be provided.
Event or Problem Description
The customer reported that the donor had gone through 4 cycles when it was observed that blood was leaking from the line and it was noted that there were air bubbles present in the line.Patient identifier unknown at this time per customer "donor states of feeling good, no adverse effects." the collection set is not available for return because it was discarded by the customer.

• Brand Name: RIKA
• Common Device Name: RIKA PLASMA SEPARATION SET
• Manufacturer (Section D): Terumo BCT; lakewood CO 80215
• Manufacturer (Section G): Terumo BCT; 10810 w. collins ave; lakewood CO 80215
• Manufacturer Contact: kristi edgington ; 10810 w. collins ave; lakewood, CO 80215
• MDR Report Key: 25071520
• Report Number: 1722028-2026-00057
• Device Sequence Number: 10747802
• Product Code: GKT
• UDI-Device Identifier: 05020583212008
• UDI-Public: 05020583212008
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: BK241097
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 6212001
• Device Lot Number: 2512192161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2026
• Supplement Date Received by Manufacturer: 07/22/2026; 08/17/2026; 09/11/2026
• Initial Report FDA Received Date: 05/04/2026
• Supplement Report FDA Received Date: 08/06/2026; 08/31/2026; 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/19/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 33 YR
• Patient Sex: Female